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About the Role
Neurona Therapeutics is seeking an experienced Device Manager to provide end-to-end technical and operational leadership for the development and commercialization of devices used in cell therapy preparation and delivery. This role ensures the integrated function of the device, cell product, and user interface as a combination product, requiring strong project management, quality systems, and regulatory knowledge.
Responsibilities
- Manage device development projects, including evaluation, selection, development, qualification, and commercialization.
- Develop and maintain device development project plans, timelines, milestones, and deliverables.
- Identify and evaluate new device technologies, components, and external manufacturers.
- Coordinate cross-functional activities with internal teams and external manufacturers.
- Establish and maintain device design controls, including user needs, requirements, specifications, reviews, and traceability.
- Develop and maintain Design History Files (DHF) and other device technical documentation.
- Coordinate device risk management activities in accordance with ISO 14971.
- Lead or coordinate use-related risk analyses, human factors studies, and usability evaluations.
- Support the development and execution of device verification and validation activities.
- Develop and execute device and cell product compatibility studies.
- Develop and execute device qualification and validation strategies.
- Collaborate with Regulatory Affairs to support device regulatory strategies and technical documentation for submissions.
- Ensure device development activities and documentation comply with FDA regulations, ISO 13485, and other relevant requirements.
- Support device-related change controls, technical assessments, investigations, and continuous improvement.
- Support device design transfer, manufacturing readiness, and lifecycle management.
- Prepare and review technical documentation, including protocols, reports, specifications, and procedures.
- Support clinical device implementation, including configuration, readiness, troubleshooting, and feedback collection.
- Proactively identify and mitigate technical, quality, and regulatory risks.
- Demonstrate ownership, accountability, and follow-through to ensure timely completion of responsibilities and project deliverables.
Requirements
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Bioengineering, or a related engineering or scientific discipline.
- Minimum of 7 years of relevant experience in medical device development, biotechnology, pharmaceuticals, or related regulated industries.
- Demonstrated experience managing medical device development projects, including coordination of cross-functional teams and external manufacturers.
- Strong knowledge and hands-on experience with medical device design controls, Design History Files (DHF), device verification and validation, and risk management.
- Experience working within regulated device and combination product quality systems, including knowledge of FDA QSR (21 CFR Part 820), 21 CFR Part 4, ISO 13485, and ISO 14971.
- Experience developing and maintaining device technical documentation.
- Understanding of regulatory requirements for medical devices and combination products.
- Experience with human factors engineering, usability evaluations, and use-related risk management.
- Demonstrated ability to independently manage complex projects and prioritize activities.
- Strong technical writing, organizational, communication, and presentation skills.
- Experience working with original equipment manufacturers (OEMs), contract manufacturers, and external device development partners preferred.
- Experience with drug-device or biologic-device combination products preferred.
- Experience with infusion pumps, syringe-based delivery systems, surgical devices, or other drug delivery technologies preferred.
- Experience developing or qualifying devices for cell or gene therapy preparation and delivery preferred.
- Experience supporting medical device development from clinical-stage use through commercial launch preferred.
- Knowledge of FDA 21 CFR Part 4, EU MDR, ISO 62366-1, and applicable international combination product regulatory requirements preferred.
- Experience preparing device-related CMC documentation and supporting combination product regulatory submissions preferred.
- Exceptional organizational and time management skills.
- Self-motivated with strong initiative, problem-solving skills, and ability to work independently and collaboratively.
Skills
- Medical device development
- Combination product development
- Project management
- Device quality systems
- Global regulatory requirements
- Technical writing
- Organizational skills
- Cross-functional team collaboration
- Design controls
- Design History Files (DHF)
- Verification and validation
- Risk management (ISO 14971)
- Human factors engineering
- Usability evaluations
- Use-related risk management
- Device verification and validation
- Device and cell product compatibility studies
- Device qualification and validation
- Regulatory submissions (INDs, BLAs)
- FDA regulations
- ISO 13485
- Change control
- Technical assessments
- Investigations
- Continuous improvement
- Design transfer
- Manufacturing readiness
- Lifecycle management
- Problem-solving
Location
- South San Francisco, CA, 94080
Work Type
- Full Time
- On-Site
Experience Level
- Minimum of 7 years of relevant experience
Education Level
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Bioengineering, or a related engineering or scientific discipline
About the Company
- Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of cell-based therapies for neurological diseases.